Last synced on 27 June 2025 at 11:06 pm

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103215
510(k) Type
Traditional
Applicant
CIANNA MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2010
Days to Decision
14 days
Submission Type
Summary

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K103215
510(k) Type
Traditional
Applicant
CIANNA MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/2010
Days to Decision
14 days
Submission Type
Summary